NCT03382639

A Study to Evaluate 3 Dose Levels of Luvadaxistat of Adults With Negative Symptoms of Schizophrenia

A Phase 2, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Subjects With Negative Symptoms of Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether add-on luvadaxistat is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).

Detailed description

The drug being tested in this study is called luvadaxistat. Luvadaxistat is being tested to treat negative symptoms in participants who have schizophrenia. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups in the double-blind period-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Luvadaxistat 50 mg once daily * Luvadaxistat 125 mg once daily * Luvadaxistat 500 mg once daily * Placebo once daily

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Luvadaxistat	TAK-831 tablets.
DRUG	Placebo	Luvadaxistat placebo-matching tablets.

Timeline

• Start date: 2018-01-04
• Primary completion: 2020-12-29
• Completion: 2021-01-12
• First posted: 2017-12-26
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

54 sites across 8 countries: United States, Bulgaria, Czechia, Germany, Italy, Poland, Spain, Ukraine

Regulatory

• FDA-regulated drug study